EBA
10 FDA 510(k) clearances · Product code
61 daysmedian time to decision
107 days90th percentile
10clearances measured
FDA profile
- Official device name
- Light, Surgical Headlight
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4630
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (K070287) | Photonic Optische Gerate GmbH & Cokg | 2007-02-12 |
| SYLVAN DENTAL HEADLIGHT SYSTEM (K923949) | Sylvan Medical Fiberoptics | 1992-10-16 |
| FIBEROPTIC HEADLIGHT SYSTEM (K893458) | Cuda Products Co. | 1989-06-22 |
| VEGA DENTAL OPERATING LIGHT (K854646) | Alpine Dental Equipment Co. | 1986-03-06 |
| SURGICAL HEADLIGHT (K842515) | Good-Lite Co. | 1984-08-02 |
| ISOLIGHT (K842358) | Planmeca USA, Inc. | 1984-07-31 |
| FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS (K822265) | Kelleher Corp. | 1982-09-28 |
| HALOGEN HEADLIGHT SYSTEM (K810117) | Colmed, Ltd. | 1981-02-10 |
| PORCELIT (K790806) | Harry J. Bosworth Co. | 1979-08-03 |
| METALIT (K790807) | Harry J. Bosworth Co. | 1979-08-03 |
Track EBA automatically
Every clearance here is in the API, with alerts when new ones post.